Drugmakers benefit ‘substantially’ from secondary patents on inhalers — study

When William Feldman was a fellow in pulmonary and critical care at Brigham and Women’s Hospital in Boston, he noticed that some patients couldn’t afford their brand-name inhalers.

On Tuesday, he and a team of researchers published evidence suggesting that drugmakers are benefiting “substantially” from staving off generic competition, even after their primary patents have expired.

William Feldman

“The patent and regulatory system in the United States should be rewarding meaningful clinical innovation — big therapeutic breakthroughs,” said Feldman, now an associate physician at Brigham. “This paper shows how lucrative it can be for manufacturers of inhalers and other products to continue to earn high revenue on molecules that were developed, in some instances, decades ago.”

Drugmakers have previously been accused of “device hopping,” or making incremental adjustments to older inhaler products to fend off generics. Feldman previously found that just 1 of 62 inhalers approved by the FDA between 1986 and 2020 had a new mechanism of action. About 85% of those were brand-name products with a median of 16 years of patent protection, according to the research published in Health Affairs.

On Tuesday, researchers published new evidence in JAMA suggesting that manufacturers listed “many more” secondary patents than primary patents from 2000 to 2021, and earned “substantially more revenue” after active ingredients went off-patent. Manufacturers raked in around $110.3 billion on inhaler lines protected only by secondary patents during the study period, according to the paper, 98% of which had accrued during periods when the drugs faced no generic competition.

For example, about 62% of GSK’s $68.2 billion in Advair revenue between 2000 and 2021 was earned after the drug’s primary patents expired, the report said. Nearly 75% of Flovent revenue came after the product’s primary patents expired, researchers added. A patient filed a class action lawsuit against the pharma giant back in May, accusing it of “device hopping” to skirt generic rivals to its brand-name inhalers, including its Ventolin, Flovent and Arnuity Ellipta lines. GSK denied those claims, and in August, the plaintiff voluntarily dismissed those claims. GSK was not available for immediate comment.

Conversely, 85% of Boehringer Ingelheim’s Spiriva sales came before primary patents had expired, according to the report.

“The current patent and regulatory system rewards minor changes to the delivery systems of existing molecules, diverting incentives for investments in new therapeutic breakthroughs,” the authors wrote.

Feldman, lead author on the JAMA paper, said potential reform could come in multiple ways, including “making sure that only high-quality patents are issued in the first place,” and “increasing the incentive for generic manufacturers to challenge patents on brand name drugs.”

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